Trial of Switching High-sensitivity Cardiac Troponin Assays in Suspected Acute Coronary Syndrome: an Interrupted Time Series Analysis (TWITCH-ED Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Edinburgh
- Enrollment
- 26,000
- Locations
- 1
- Primary Endpoint
- Proportion of patients with suspected acute coronary syndrome admitted to hospital
Study Overview
Brief Summary
Cardiac troponin is central to the diagnosis of myocardial infarction and high-sensitivity cardiac troponin (hs-cTn) assays are the preferred choice for the assessment of patients with suspected acute coronary syndrome.
Since the introduction of hs-cTn assays in Europe in 2010, most hospitals have switched from contemporary sensitive cardiac troponin assays to a hs-cTn assay. The implementation of hs-cTn assays has led to an increase in the number of patients identified with myocardial injury. Although both hs-cTnI and hs-cTnT assays are recommended in current guidelines, the impact of switching from a hs-cTnI assay to a hs-cTnT assay on clinical practice is unknown. At this point, no studies have evaluated the impact of implementing sex-specific hs-cTnT thresholds on the diagnosis of myocardial infarction and outcome in clinical practice.
The investigators propose to determine the proportion of patients with and without myocardial injury admitted to the hospital before and after implementation of a hs-cTnT assay and to evaluate the impact on investigations, care and clinical outcomes in consecutive patients with suspected acute coronary syndrome.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years and over
- •Symptoms of possible acute coronary syndrome
- •High-sensitivity cardiac troponin measured at presentation
Exclusion Criteria
- •Insufficient clinical information to perform record linkage
- •Previous enrolment in the study
- •Patients with ST-segment elevation myocardial infarction (STEMI)
Outcomes
Primary Outcomes
Proportion of patients with suspected acute coronary syndrome admitted to hospital
Time Frame: Up to 24 hours
To determine the proportion of patients with and without myocardial injury admitted to the hospital before and after implementation of the hs-cTnT assay
Secondary Outcomes
- Length of hospital stay(Up to 30 days)
- Cardiovascular death at 30 days and one year(30 days and 1 year)
- Subsequent heart failure at 30 days and one year(30 days and 1 year)
- Proportion of patients with myocardial injury admitted to hospital(Up to 24 hours)
- Clinical diagnosis of myocardial infarction(Up to 24 hours)
- Clinical diagnosis of heart failure(Up to 24 hours)
- Coronary angiography during hospital admission(Up to 30 days)
- Reattendance with suspected acute coronary syndrome at 30 days and one year(30 days and 1 year)
- Subsequent myocardial infarction at 30 days and one year(30 days and 1 year)
- Echocardiography during hospital admission(Up to 30 days)
- New prescription of evidence-based treatment for coronary artery disease or heart failure following discharge(Up to 30 days)
- Revascularization at 30 days and one year(30 days and 1 year)
- Subsequent myocardial infarction, heart failure or cardiovascular death at 30 days and one year(30 days and 1 year)
- All-cause death at 30 days and one year(30 days and 1 year)